Protocol summary

Study aim
The effect of aromatherapy of rose petals on sexual function of postmenopausal women
Design
The clinical trial has intervention and control groups; parallel groups; randomized; in each group 57 people are assigned using the random permutation block method.
Settings and conduct
The intervention group received 2-3 drops of 10% rosemary solution three times a day for 6 weeks on the forearm by inhalation and the placebo group received distilled water solution like the intervention group.
Participants/Inclusion and exclusion criteria
Age between 45 and 60 years, natural menopause, more than 12 months passed since the last menstrual period, living with a spouse and having sexual activity, body mass index 18.5 to 29.9, achieving the quorum score in the DASS_21 questionnaire, achieving the quorum FSFI questionnaire scores at the level of moderate sexual dysfunctio
Intervention groups
Intervention group: improvement of sexual function in postmenopausal women with rosehip extract Control group: improvement of sexual performance in postmenopausal women without using rosehips with distilled water
Main outcome variables
The main outcome in this study is the improvement of sexual performance, the score given by the research units from the response to the FSFI sexual performance index questionnaire, which examines the dimensions of sexual desire, psychological stimulation, arousal, moisture, orgasm, satisfaction and pain.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220621055245N1
Registration date: 2022-07-16, 1401/04/25
Registration timing: prospective

Last update: 2022-07-16, 1401/04/25
Update count: 0
Registration date
2022-07-16, 1401/04/25
Registrant information
Name
nasrin vahdani Rashvanlouyi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3242 4581
Email address
vahdani.n.midwifery@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2022-09-22, 1401/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aromatherapy with Rose petal aqueous extract on sexual function of postmenopausal women
Public title
The effect of aromatherapy with Rose petal aqueous extract on sexual function of postmenopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 45 and 60 years, menopause occurs naturally, more than 12 months have passed since the last menstruation, living with a spouse and having sexual activity, body mass index 18.5 to 29.9, absence of addiction and drug use, not using any drugs that affect Sexual function, not having a known systemic disease affecting sexual function, no disturbance in the sense of smell No history of using aromatherapy, no sensitivity to rosehip compounds, no problem of spouse in sexual relations, obtaining the quorum score in the DASS_21 questionnaire, obtaining the quorum score in the FSFI questionnaire at the level of moderate sexual dysfunction
Exclusion criteria:
Reluctance to enter the study Not having a sexual partner premature menopause People do not have the ability to understand Farsi language The presence of psychiatric problems History of hospitalization in psychiatric hospitals
Age
From 45 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 57
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling in random categories will be proportional to the volume of floors, so that each of the comprehensive health service centers in Gonabad is considered as a floor and from each center is calculated according to the sample size and proportional to the number The population covered by each center, from the list of covered people, research samples will be randomly selected and randomly assigned to the aromatherapy or control group using permutation blocks.Random permutation blocks of sizes 2 and 4 will be used for randomization. The analyzer will determine the randomization list based on a web-based randomization program. The allocation will be concealed using opaque sealed envelopes with a random sequence.
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding will be done for the data analyzer. For the study groups, A and B codes are considered, and the data analyzer is not told the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Gonabad University of Medical Scienses
Street address
17 September South .Farabi .Farabi 3. No. 49
City
Bojunord
Province
North Khorasan
Postal code
9413653514
Approval date
2022-06-06, 1401/03/16
Ethics committee reference number
IR.GMU.REC.1401.032

Health conditions studied

1

Description of health condition studied
The effect of rosemary extract on postmenopausal women
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Sexual function
Timepoint
At the beginning of the study, immediately after the intervention (two weeks after the start of the intervention) and one month after the intervention, participants in both groups will complete the sexual function index questionnaire again.
Method of measurement
ّFSFI questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, 2-3 drops of 10% rosehip solution (prepared at Pars Tek Rokh Company) are inhaled three times a day for 6 weeks on the forearm to ensure the correctness of the intervention, once a week. The participants will be contacted and a daily checklist will be given to the people to mark every day after the intervention and the complication form will be filled by the participants during the study in case of problems. Immediately after the end of the intervention (two weeks after the start of the intervention) and one month after the end of the intervention, the participants in both groups will complete the sexual performance index questionnaire again.
Category
Treatment - Drugs

2

Description
Control group: Distilled water solution is inhaled 3 times a day for 6 weeks on the forearm. In order to ensure the correctness of the intervention, the participants are contacted once a week and a daily checklist is given to the individuals to mark every day after the intervention, and the complication form during the study in case of any problem by the participation. will be filled. Immediately after the end of the intervention (two weeks after the start of the intervention) and one month after the end of the intervention, the participants in both groups will complete the sexual performance index questionnaire again.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Gonabad Comprehensive Health Service Centers
Full name of responsible person
Nasrin Vahdani Rashvanlouyi
Street address
No. 49 Farabi3.Farabi.17 September
City
Boujnord
Province
North Khorasan
Postal code
941365314
Phone
+98 915 992 4493
Email
vahdani.n.midwifery@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Postgraduate expert
Street address
Khorasan Razavi, Gonabad, Imam Khomeini St., Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
6535149413
Phone
+98 51 5722 5027
Email
info@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad University of Medical Sciences
Proportion provided by this source
30
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Nasrin Vahdani Rashvanlouyi
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
17 September South .Farabi .Nabsh Farabi 3 No. 49
City
Boujnord
Province
North Khorasan
Postal code
9413653514
Phone
+98 58 3242 4581
Email
vahdani.n.midwifery@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Nasrin Vahdani Rashvanlouyi
Position
Master student of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
17 September South .Farabi .Nabsh Farabi 3 No. 49
City
Boujnord
Province
North Khorasan
Postal code
9413655314
Phone
+98 58 3242 4581
Email
vahdani.n.midwifery@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Nasrin Vahdani Rashvanlouyi
Position
Master student of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
17 September South Farabi .Farabi 3. No. 49
City
Boujnord
Province
North Khorasan
Postal code
9413653514
Phone
+98 58 3242 4581
Email
vahdani.n.midwifery@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Participants are coded to increase access to them and their information, but at the time of publication, only the main outcome is published and the participants' information is not published at all.
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
Access is open to the public
Under which criteria data/document could be used
If people request, without mentioning the coding of information confidentially, without personal information, only the main and side consequences will be provided to the applicant.
From where data/document is obtainable
E-mail
What processes are involved for a request to access data/document
The applicant must first e-mail the message and state its use. Information will be sent within a week with conditions and restrictions for use.
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